Table 1B. Baseline Patient Demographics and Clinical Characteristics of Patients (Study Period IV).
| Characteristic | SPIV OFC, N=221 | SPIV FLU, N=223 | p-value |
|---|---|---|---|
| Age (years), mean (SD) | 44.9 (11.8) | 44.1 (12.3) | 0.404a |
| Gender, n (%) | 0.378b | ||
| Male | 78 (35.3) | 70 (31.4) | |
| Female | 143 (64.7) | 153 (68.6) | |
| Race, n (%) | |||
| Caucasian | 156 (70.6) | 158 (70.9) | |
| Other | 63 (28.6) | 65 (29.1) | |
| Body Weight (kg), mean (SD) | 84.1 (22.0) | 82.2 (21.1) | 0.289a |
| Height (cm), mean (SD) | 165.8 (9.1) | 164.9 (9.5) | 0.298a |
| BMI (kg/m2), mean (SD) | 30.5 (6.9) | 30.2 (7.5) | 0.174a |
| Age at first episode (years), mean (SD) | 31.7 (12.4) | 31.7 (13.4) | 0.963a |
| Age at current episode (years), mean (SD) | 43.1 (12.2) | 42.1 (12.3) | 0.349a |
| Number of previous episodesc, mean (SD) | 3.5 (4.2) | 3.8 (9.7) | 0.619a |
| Duration of current episode (days), mean (SD) | 546.3 (972.7) | 640.2 (1171.4) | 0.461a |
| MADRS total scored, mean (SD) | 5.4 (3.8) | 5.4 (4.0) | 0.871a |
| CGI-S scoree, mean (SD) | 1.7 (0.7) | 1.7 (0.8) | 0.491a |
Abbreviations: ANOVA, analysis of variance; BMI, body mass index; CGI-S, Clinical Global Impressions-Severity of Depression; CMH, Cochran-Mantel-Haenszel; FLU, fluoxetine; LS, least squares; MADRS, Montgomery-Åsberg Depression Rating Scale; N, number of patients involved in the summary; n, number of patients in the given category; OFC, olanzapine and fluoxetine hydrochloride combination; SD, standard deviation; SE, standard error; SP, study period.
p-values are from ANOVA with treatment and country as independent variables in the model.
p-values are from CMH test adjusting by country.
Does not include current episode.
MADRS mean change at endpoint (LS Mean (SE)): 3.0 (0.7), OFC; 6.8 (0.7), FLU; p<0.001.
CGI-S mean change at endpoint (LS Mean (SE)): 0.2 (0.1), OFC; 0.5 (0.1), FLU; p=0.002.